81_FR_68606 81 FR 68414 - Human Studies Review Board; Notification of Public Meetings

81 FR 68414 - Human Studies Review Board; Notification of Public Meetings

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 192 (October 4, 2016)

Page Range68414-68415
FR Document2016-23987

The Environmental Protection Agency (EPA) Office of the Science Advisor announces two separate public meetings of the Human Studies Review Board (HSRB) to advise the Agency on the ethical and scientific review of research involving human subjects.

Federal Register, Volume 81 Issue 192 (Tuesday, October 4, 2016)
[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Pages 68414-68415]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23987]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9953-70-ORD]


Human Studies Review Board; Notification of Public Meetings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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[[Page 68415]]

SUMMARY: The Environmental Protection Agency (EPA) Office of the 
Science Advisor announces two separate public meetings of the Human 
Studies Review Board (HSRB) to advise the Agency on the ethical and 
scientific review of research involving human subjects.

DATES: A public virtual meeting will be held on October 19-20, 2016, 
from 1:00 p.m. to approximately 5:00 p.m. Eastern Time each day. A 
separate, subsequent teleconference meeting is planned for Tuesday, 
December 13, 2016, from 2:00 p.m. to approximately 3:30 p.m. for the 
HSRB to finalize its Final Report of the October 19-20, 2016 meeting.

ADDRESSES: Both of these meetings will be conducted entirely by 
telephone and on the Internet using Adobe Connect. For detailed access 
information visit the HSRB Web site: http://www2.epa.gov/osa/human-studies-review-board.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to 
receive further information should contact the HSRB Designated Federal 
Official, Jim Downing on telephone number (202) 564-2468; fax number: 
(202) 564-2070; email address: [email protected]; or mailing address: 
Environmental Protection Agency, Office of the Science Advisor, Mail 
code 8105R, 1200 Pennsylvania Avenue NW., Washington, DC 20460.

SUPPLEMENTARY INFORMATION: 
    Meeting access: These meetings are open to the public. Meeting 
materials are available at the HSRB Web site: http://www2.epa.gov/osa/human-studies-review-board for questions on document availability, or 
if you do not have access to the Internet, consult with Jim Downing 
listed under FOR FURTHER INFORMATION CONTACT.
    Special accommodations. For information on access or services for 
individuals with disabilities, or to request accommodation of a 
disability, please contact Jim Downing listed under FOR FURTHER 
INFORMATION CONTACT at least 10 days prior to the meeting to give EPA 
as much time as possible to process your request.

How may I participate in this meeting?

    The HSRB encourages the public's input. You may participate in 
these meetings by following the instructions in this section.
    1. Oral comments. Requests to present oral comments during either 
conference call will be accepted up to Noon Eastern Time on Wednesday, 
October 12, 2016, for the October 19-20, 2016 meeting and up to Noon 
Eastern Time on Thursday, December 8, 2016 for the December 13, 2016 
conference call. To the extent that time permits, interested persons 
who have not pre-registered may be permitted by the HSRB Chair to 
present oral comments during either call at the designated time on the 
agenda. Oral comments before the HSRB are generally limited to five 
minutes per individual or organization. If additional time is 
available, further public comments may be possible.
    2. Written comments. Submit your written comments prior to the 
meetings. For the Board to have the best opportunity to review and 
consider your comments as it deliberates, you should submit your 
comments by Noon Eastern Time on Wednesday, October 12, 2016, for the 
October 19-20, 2016 conference call, and by noon Eastern Time on 
Thursday, December 8, 2016 for the December 13, 2016 teleconference. If 
you submit comments after these dates, those comments will be provided 
to the HSRB members, but you should recognize that the HSRB members may 
not have adequate time to consider your comments prior to their 
discussion. You should submit your comments to Jim Downing listed under 
FOR FURTHER INFORMATION CONTACT. There is no limit on the length of 
written comments for consideration by the HSRB.

Background

    The HSRB is a Federal advisory committee operating in accordance 
with the Federal Advisory Committee Act 5 U.S.C. App. 2 Sec.  9. The 
HSRB provides advice, information, and recommendations on issues 
related to scientific and ethical aspects of human subjects research 
that are submitted to the Office of Pesticide Programs to be used for 
regulatory purposes. The major objectives of the HSRB are to provide 
advice and recommendations on: (1) Research proposals and protocols; 
(2) reports of completed research with human subjects; and (3) how to 
strengthen EPA's programs for protection of human subjects of research.
    Topics for discussion. On Wednesday, October 19, 2016, EPA's Human 
Studies Review Board will consider a Protocol for Laboratory Evaluation 
of Mosquito Bite Protection from Permethrin-treated Clothing for the 
U.S. Army after 0, 20 and/or 50 washings. On Thursday, October 20, 2016 
the HSRB will consider: A Study for Measurement of Potential Dermal and 
Inhalation Exposure during Manual Pouring of Two Solid Formulations 
Containing an Antimicrobial. Meeting materials for these two topics 
will be available in advance of the meeting at http://www2.epa.gov/osa/human-studies-review-board.
    On December 13, 2016, the Human Studies Review Board will review 
and finalize their draft Final Report from the October 19-20, 2016 
meeting. The draft report will be available prior to the conference 
call at http://www2.epa.gov/osa/human-studies-review-board.
    Meeting minutes and final reports. Minutes of these meetings, 
summarizing the matters discussed and recommendations made by the HSRB, 
will be released within 90 calendar days of the meeting. These minutes 
will be available at http://www2.epa.gov/osa/human-studies-review-board. In addition, information regarding the HSRB's Final Report, will 
be found at http://www2.epa.gov/osa/human-studies-review-board or from 
Jim Downing listed under FOR FURTHER INFORMATION CONTACT.

Thomas A. Burke,
EPA Science Advisor.
[FR Doc. 2016-23987 Filed 10-3-16; 8:45 am]
 BILLING CODE 6560-50-P



                                                  68414                        Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices

                                                  ENVIRONMENTAL PROTECTION                                to attain and maintain air quality                    information. Members of the public
                                                  AGENCY                                                  standards. The CASAC is a Federal                     wishing to provide comment should
                                                                                                          Advisory Committee chartered under                    contact the DFO directly.
                                                  [FRL–9953–67–OA]
                                                                                                          the Federal Advisory Committee Act                       Oral Statements: In general,
                                                  Notification of a Public Meeting of the                 (FACA), 5 U.S.C., App. 2. Section                     individuals or groups requesting an oral
                                                  Clean Air Scientific Advisory                           109(d)(1) of the CAA requires that the                presentation at a public meeting will be
                                                  Committee (CASAC) Oxides of                             Agency periodically review and revise,                limited to five minutes. Each person
                                                  Nitrogen Primary NAAQS Review Panel                     as appropriate, the air quality criteria              making an oral statement should
                                                                                                          and the NAAQS for the six ‘‘criteria’’ air            consider providing written comments as
                                                  AGENCY: Environmental Protection                        pollutants, including oxides of nitrogen.             well as their oral statement so that the
                                                  Agency (EPA).                                           EPA is currently reviewing the primary                points presented orally can be expanded
                                                  ACTION: Notice.                                         (health-based) NAAQS for nitrogen                     upon in writing. Interested parties
                                                                                                          dioxide (NO2) as an indicator for health              should contact Mr. Aaron Yeow, DFO,
                                                  SUMMARY:    The EPA Science Advisory                    effects caused by the presence of oxides              in writing (preferably via email) at the
                                                  Board (SAB) Staff Office announces a                    of nitrogen in the ambient air.                       contact information noted above by
                                                  public meeting of the Clean Air                            Pursuant to FACA and EPA policy,                   November 2, 2016, to be placed on the
                                                  Scientific Advisory Committee (CASAC)                   notice is hereby given that the CASAC                 list of public speakers. Written
                                                  Oxides of Nitrogen Primary National                     Oxides of Nitrogen Primary NAAQS                      Statements: Written statements will be
                                                  Ambient Air Quality Standards                           Review Panel will hold a public meeting               accepted throughout the advisory
                                                  (NAAQS) Review Panel to peer review                     to peer review EPA’s Policy Assessment                process; however, for timely
                                                  EPA’s Policy Assessment for the Review                  for the Review of the Primary National                consideration by Panel members,
                                                  of the Primary National Ambient Air                     Ambient Air Quality Standards for                     statements should be supplied to the
                                                  Quality Standards for Nitrogen Dioxide                  Nitrogen Dioxide (External Review                     DFO (preferably via email) at the contact
                                                  (External Review Draft—September                        Draft—September 2016). The CASAC                      information noted above by November
                                                  2016).                                                  Oxides of Nitrogen Primary NAAQS                      2, 2016. It is the SAB Staff Office
                                                  DATES: The CASAC Oxides of Nitrogen                     Review Panel and the CASAC will                       general policy to post written comments
                                                  Primary NAAQS Review Panel meeting                      comply with the provisions of FACA                    on the Web page for the advisory
                                                  will be on Wednesday, November 9,                       and all appropriate SAB Staff Office                  meeting or teleconference. Submitters
                                                  2016 from 9:00 a.m. to 5:00 p.m.                        procedural policies.                                  are requested to provide an unsigned
                                                  (Eastern Time) and on Thursday,                            Technical Contacts: Any technical                  version of each document because the
                                                  November 10, 2016 from 8:30 a.m. to                     questions concerning the Policy                       SAB Staff Office does not publish
                                                  12:30 p.m. (Eastern Time).                              Assessment for the Review of the                      documents with signatures on its Web
                                                  LOCATION: The public meeting will be
                                                                                                          Primary National Ambient Air Quality
                                                                                                                                                                sites. Members of the public should be
                                                  held at the Embassy Suites by Hilton                    Standards for Nitrogen Dioxide
                                                                                                                                                                aware that their personal contact
                                                  Alexandria Old Town, 1900 Diagonal                      (External Review Draft—September
                                                                                                                                                                information, if included in any written
                                                                                                          2016) should be directed to Dr. Jennifer
                                                  Road, Alexandria, Virginia 22314.                                                                             comments, may be posted to the CASAC
                                                                                                          Nichols (nichols.jennifer@epa.gov), EPA
                                                  FOR FURTHER INFORMATION CONTACT: Any                                                                          Web site. Copyrighted material will not
                                                                                                          Office of Air and Radiation.
                                                  member of the public wishing to obtain                     Availability of Meeting Materials:                 be posted without explicit permission of
                                                  information concerning the public                       Prior to the meeting, the review                      the copyright holder.
                                                  meeting may contact Mr. Aaron Yeow,                     documents, agenda and other materials                    Accessibility: For information on
                                                  Designated Federal Officer (DFO), EPA                   will be accessible on the CASAC Web                   access or services for individuals with
                                                  Science Advisory Board Staff Office                     site at http://www.epa.gov/casac/.                    disabilities, please contact Mr. Aaron
                                                  (1400R), U.S. Environmental Protection                     Procedures for Providing Public Input:             Yeow at the contact information
                                                  Agency, 1200 Pennsylvania Avenue                        Public comment for consideration by                   provided above. To request
                                                  NW., Washington, DC 20460; by                           EPA’s federal advisory committees and                 accommodation of a disability, please
                                                  telephone at (202) 564–2050 or via                      panels has a different purpose from                   contact Mr. Yeow preferably at least ten
                                                  email at yeow.aaron@epa.gov. General                    public comment provided to EPA                        days prior to each meeting to give EPA
                                                  information about the CASAC, as well                    program offices. Therefore, the process               as much time as possible to process
                                                  as any updates concerning the meeting                   for submitting comments to a federal                  your request.
                                                  announced in this notice, may be found                  advisory committee is different from the               Dated: September 28, 2016.
                                                  on the CASAC Web site at http://                        process used to submit comments to an                 Khanna Johnston,
                                                  www.epa.gov/casac.                                      EPA program office.                                   Acting Deputy Director, EPA Science
                                                  SUPPLEMENTARY INFORMATION: The                             Federal advisory committees and                    Advisory Staff Office.
                                                  CASAC was established pursuant to the                   panels, including scientific advisory                 [FR Doc. 2016–23974 Filed 10–3–16; 8:45 am]
                                                  Clean Air Act (CAA) Amendments of                       committees, provide independent                       BILLING CODE 6560–50–P
                                                  1977, codified at 42 U.S.C. 7409(d)(2), to              advice to EPA. Members of the public
                                                  review air quality criteria and NAAQS                   can submit relevant comments on the
                                                  and recommend any new NAAQS and                         topic of this advisory activity, including            ENVIRONMENTAL PROTECTION
                                                  revisions of existing criteria and                      the charge to the panel and the EPA                   AGENCY
                                                  NAAQS as may be appropriate. The                        review documents, and/or the group
                                                  CASAC shall also provide advice,                        conducting the activity, for the CASAC                [FRL–9953–70–ORD]
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                                                  information, and recommendations to                     to consider during the advisory process.
                                                  the Administrator on the scientific and                 Input from the public to the CASAC will               Human Studies Review Board;
                                                  technical aspects of issues related to the              have the most impact if it provides                   Notification of Public Meetings
                                                  criteria for air quality standards,                     specific scientific or technical                      AGENCY: Environmental Protection
                                                  research related to air quality, sources of             information or analysis for CASAC                     Agency (EPA).
                                                  air pollution, and of adverse effects                   panels to consider or if it relates to the
                                                                                                                                                                ACTION: Notice.
                                                  which may result from various strategies                clarity or accuracy of the technical


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                                                                               Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices                                                 68415

                                                  SUMMARY:    The Environmental Protection                have not pre-registered may be                           On December 13, 2016, the Human
                                                  Agency (EPA) Office of the Science                      permitted by the HSRB Chair to present                Studies Review Board will review and
                                                  Advisor announces two separate public                   oral comments during either call at the               finalize their draft Final Report from the
                                                  meetings of the Human Studies Review                    designated time on the agenda. Oral                   October 19–20, 2016 meeting. The draft
                                                  Board (HSRB) to advise the Agency on                    comments before the HSRB are                          report will be available prior to the
                                                  the ethical and scientific review of                    generally limited to five minutes per                 conference call at http://www2.epa.gov/
                                                  research involving human subjects.                      individual or organization. If additional             osa/human-studies-review-board.
                                                  DATES: A public virtual meeting will be                 time is available, further public                        Meeting minutes and final reports.
                                                  held on October 19–20, 2016, from 1:00                  comments may be possible.                             Minutes of these meetings, summarizing
                                                  p.m. to approximately 5:00 p.m. Eastern                   2. Written comments. Submit your                    the matters discussed and
                                                  Time each day. A separate, subsequent                   written comments prior to the meetings.               recommendations made by the HSRB,
                                                  teleconference meeting is planned for                   For the Board to have the best                        will be released within 90 calendar days
                                                  Tuesday, December 13, 2016, from 2:00                   opportunity to review and consider your               of the meeting. These minutes will be
                                                  p.m. to approximately 3:30 p.m. for the                 comments as it deliberates, you should                available at http://www2.epa.gov/osa/
                                                  HSRB to finalize its Final Report of the                submit your comments by Noon Eastern                  human-studies-review-board. In
                                                  October 19–20, 2016 meeting.                            Time on Wednesday, October 12, 2016,                  addition, information regarding the
                                                  ADDRESSES: Both of these meetings will                  for the October 19–20, 2016 conference                HSRB’s Final Report, will be found at
                                                  be conducted entirely by telephone and                  call, and by noon Eastern Time on                     http://www2.epa.gov/osa/human-
                                                  on the Internet using Adobe Connect.                    Thursday, December 8, 2016 for the                    studies-review-board or from Jim
                                                  For detailed access information visit the               December 13, 2016 teleconference. If                  Downing listed under FOR FURTHER
                                                  HSRB Web site: http://www2.epa.gov/                     you submit comments after these dates,                INFORMATION CONTACT.
                                                  osa/human-studies-review-board.                         those comments will be provided to the                Thomas A. Burke,
                                                  FOR FURTHER INFORMATION CONTACT: Any                    HSRB members, but you should                          EPA Science Advisor.
                                                  member of the public who wishes to                      recognize that the HSRB members may
                                                                                                                                                                [FR Doc. 2016–23987 Filed 10–3–16; 8:45 am]
                                                  receive further information should                      not have adequate time to consider your
                                                                                                                                                                BILLING CODE 6560–50–P
                                                  contact the HSRB Designated Federal                     comments prior to their discussion. You
                                                  Official, Jim Downing on telephone                      should submit your comments to Jim
                                                  number (202) 564–2468; fax number:                      Downing listed under FOR FURTHER
                                                                                                          INFORMATION CONTACT. There is no limit
                                                                                                                                                                FEDERAL COMMUNICATIONS
                                                  (202) 564–2070; email address:                                                                                COMMISSION
                                                  downing.jim@epa.gov; or mailing                         on the length of written comments for
                                                  address: Environmental Protection                       consideration by the HSRB.                            [OMB 3060–1079]
                                                  Agency, Office of the Science Advisor,                  Background                                            Information Collection Being Reviewed
                                                  Mail code 8105R, 1200 Pennsylvania
                                                                                                             The HSRB is a Federal advisory                     by the Federal Communications
                                                  Avenue NW., Washington, DC 20460.
                                                                                                          committee operating in accordance with                Commission Under Delegated
                                                  SUPPLEMENTARY INFORMATION:
                                                                                                          the Federal Advisory Committee Act 5                  Authority
                                                    Meeting access: These meetings are
                                                  open to the public. Meeting materials                   U.S.C. App. 2 § 9. The HSRB provides                  AGENCY: Federal Communications
                                                  are available at the HSRB Web site:                     advice, information, and                              Commission.
                                                  http://www2.epa.gov/osa/human-                          recommendations on issues related to
                                                                                                                                                                ACTION: Notice and request for
                                                  studies-review-board for questions on                   scientific and ethical aspects of human
                                                                                                                                                                comments.
                                                  document availability, or if you do not                 subjects research that are submitted to
                                                  have access to the Internet, consult with               the Office of Pesticide Programs to be                SUMMARY:   As part of its continuing effort
                                                  Jim Downing listed under FOR FURTHER                    used for regulatory purposes. The major               to reduce paperwork burdens, and as
                                                  INFORMATION CONTACT.
                                                                                                          objectives of the HSRB are to provide                 required by the Paperwork Reduction
                                                     Special accommodations. For                          advice and recommendations on: (1)                    Act (PRA) of 1995 (44 U.S.C. 3501–
                                                  information on access or services for                   Research proposals and protocols; (2)                 3520), the Federal Communications
                                                  individuals with disabilities, or to                    reports of completed research with                    Commission (FCC or Commission)
                                                  request accommodation of a disability,                  human subjects; and (3) how to                        invites the general public and other
                                                  please contact Jim Downing listed under                 strengthen EPA’s programs for                         Federal agencies to take this
                                                  FOR FURTHER INFORMATION CONTACT at                      protection of human subjects of                       opportunity to comment on the
                                                  least 10 days prior to the meeting to give              research.                                             following information collections.
                                                  EPA as much time as possible to process                    Topics for discussion. On Wednesday,               Comments are requested concerning:
                                                  your request.                                           October 19, 2016, EPA’s Human Studies                 Whether the proposed collection of
                                                                                                          Review Board will consider a Protocol                 information is necessary for the proper
                                                  How may I participate in this meeting?                  for Laboratory Evaluation of Mosquito                 performance of the functions of the
                                                    The HSRB encourages the public’s                      Bite Protection from Permethrin-treated               Commission, including whether the
                                                  input. You may participate in these                     Clothing for the U.S. Army after 0, 20                information shall have practical utility;
                                                  meetings by following the instructions                  and/or 50 washings. On Thursday,                      the accuracy of the Commission’s
                                                  in this section.                                        October 20, 2016 the HSRB will                        burden estimate; ways to enhance the
                                                    1. Oral comments. Requests to present                 consider: A Study for Measurement of                  quality, utility, and clarity of the
                                                  oral comments during either conference                  Potential Dermal and Inhalation                       information collected; ways to minimize
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                                                  call will be accepted up to Noon Eastern                Exposure during Manual Pouring of                     the burden of the collection of
                                                  Time on Wednesday, October 12, 2016,                    Two Solid Formulations Containing an                  information on the respondents,
                                                  for the October 19–20, 2016 meeting and                 Antimicrobial. Meeting materials for                  including the use of automated
                                                  up to Noon Eastern Time on Thursday,                    these two topics will be available in                 collection techniques or other forms of
                                                  December 8, 2016 for the December 13,                   advance of the meeting at http://                     information technology; and ways to
                                                  2016 conference call. To the extent that                www2.epa.gov/osa/human-studies-                       further reduce the information
                                                  time permits, interested persons who                    review-board.                                         collection burden on small business


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Document Created: 2016-10-04 03:04:15
Document Modified: 2016-10-04 03:04:15
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesA public virtual meeting will be held on October 19-20, 2016, from 1:00 p.m. to approximately 5:00 p.m. Eastern Time each day. A separate, subsequent teleconference meeting is planned for Tuesday, December 13, 2016, from 2:00 p.m. to approximately 3:30 p.m. for the HSRB to finalize its Final Report of the October 19-20, 2016 meeting.
ContactAny member of the public who wishes to receive further information should contact the HSRB Designated Federal Official, Jim Downing on telephone number (202) 564-2468; fax number:
FR Citation81 FR 68414 

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